Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula to calculate Spore Log Reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator is: SLR = Log10…
read more#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in the production of sterile pharmaceutical products. It is the assurance that the final product is free of any viable microorganisms, which can…
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read moreThe F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the load in its container with reference to micro-organisms possessing…
read moreUnderstanding BI COA is one of the critical task for Non-Microbiology professional. I will be come up with number of sequel articles to understand the complete BI COA. In this article we majorly discussed about the survival time and killing time BI’s….
read moreMonitoring of bioburden is one of the most important aspect of terminal sterilization. Before sterilization all samples to be collected based on the predetermined interval to cover the complete process/manufacturing time. Sample to be collected in the final container to represent to…
read moreWhat is infection? The invasion and multiplication of microorganisms such as bacteria, viruses, and parasites that are not normally present within the body. An infection may cause no symptoms and be subclinical, or it may cause symptoms and be clinically apparent. An…
read moreWhen the bioburden method is employed for sterilization process, the bioburden trend of materials and products should be routinely and frequently monitored and, if more heat-resistant microorganisms are identified, then method should re-validate and the potential effect of the microorganisms on pharmaceutical…
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